Global Clinical Project Manager Rare Disease H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

Join Excelya, whereAudacity, Care, and Energydefine who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

- Lead the global management of outsourced Phase II-III clinical trials, ensuring alignment with sponsor expectations, timelines, and quality standards.
- Act as the primary point of contact for internal sponsor teams and CROs, driving collaborative decision-making and proactive issue resolution.
- Review and validate project plans developed by CROs, including risk mitigation, escalation strategy, and communication plans.
- Oversee study budgets, monitor expenses, and ensure financial reporting in coordination with CROs and sponsor finance teams.
- Ensure trials are conducted according to ICH-GCP, SOPs, and applicable regulatory requirements across all geographies.
- Supervise cross-functional study teams, fostering coordination between Clinical Operations, Medical, Biometry, Pharmacovigilance, and CMC.
- Manage vendor and site relationships, including feasibility, selection, contracting, and performance follow-up.
- Review critical study documentation: protocols, CRFs, risk management plans, and recruitment strategies.
- Participate in audits and inspections, ensure CAPA implementation, and support continuous improvement initiatives.
- Contribute to study reporting and results publication in clinical registries, in compliance with transparency regulations.